Systems and methods for removing materials from the pancreas using an endoscopic surgical tool

ABSTRACT

A method for removing materials from a subject can include inserting an endoscope into the subject through an esophagus of the subject; introducing, through a cavity wall of a stomach of the subject to access a site within the subject outside the stomach, an endoscopic tool coupled with the endoscope; actuating a cutting assembly of the endoscopic tool to cut material at the site, the material associated with at least one of a pancreatic fluid collection in a pancreas of the subject or an extra-pancreatic fluid collection external to the pancreas; and applying suction to a first end of an aspiration channel of the endoscopic tool to remove the material through the aspiration channel, the aspiration channel extending from the first end to a second end at an opening of the cutting assembly.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.16/428,146, titled “SYSTEMS AND METHODS FOR REMOVING MATERIALS FROM THEPANCREAS USING AN ENDOSCOPIC SURGICAL TOOL,” filed May 31, 2019, whichclaims the benefit of priority to U.S. Provisional Application No.62/679,559, titled “METHODS FOR REMOVING MATERIALS FROM THE PANCREASUSING AN ENDOSCOPIC SURGICAL TOOL,” filed Jun. 1, 2018, and U.S.Provisional Application No. 62/682,634, titled “METHODS FOR REMOVINGMATERIALS FROM THE PANCREAS USING AN ENDOSCOPIC SURGICAL TOOL,” filedJun. 8, 2018, the entire disclosure of each of which is incorporatedherein for any and all purposes.

BACKGROUND

The present disclosure relates generally to pancreatic procedures. Moreparticularly, the present disclosure relates to systems and methods ofremoving material from the pancreas and peri pancreatic collectionsusing an endoscopic tool.

Acute pancreatitis may run a severe course when pancreatic necrosisbecomes infected. In existing procedures, invasive treatment of subjectsis typically performed. Existing endoscopic procedures may be limited inthe ability to remove necrotic tissue, resulting in time consumingprocedures with marginal results and often necessitating multipleprocedures.

SUMMARY

The present solution uses an endoscopic tool, such as the ENDOROTORmanufactured by Interscope, Inc. of Whitinsville, Mass., to suck, cutand remove small pieces of tissue in subjects with necrotizingpancreatitis.

At least one aspect relates to a method for removing materials from asubject. The method can include inserting an endoscope into the subjectthrough an esophagus of the subject; introducing, an endoscope via aNatural Orifice Transluminal Endoscopic Surgical (NOTES) procedurereferred to as cyst-gastrotomy connecting or anastomosing a peripancreatic or pancreatic fluid collection to the wall of a stomach ofthe subject to access a site within the subject outside the stomach, anendoscopic tool coupled with the endoscope; actuating a cutting assemblyof the endoscopic tool to cut material at the site, the materialassociated with at least one of a pancreatic/peri-pancreatic fluidcollection in a pancreas of the subject or an extra-pancreatic fluidcollection external to the pancreas; and applying suction to a first endof an aspiration channel of the endoscopic tool to remove the materialthrough the aspiration channel, the aspiration channel extending fromthe first end to a second end at an opening of the cutting assembly.

At least one aspect relates to a system for removing material from asubject. The system can include at least one stent or cyst gastrotomyconfigured to generate at least one opening to enable access to thematerial. The material can be associated with at least one of apancreatic fluid collection in a pancreas of the subject or anextra-pancreatic fluid collection external to the pancreas. The systemcan include an endoscope that includes an instrument channel and/or anaccessory channel disposed outside of the endoscope. The system caninclude an endoscopic tool coupled with the endoscope. The endoscopictool can include a cutting assembly comprising an outer cannula and aninner cannula disposed within the outer cannula; a flexible outer tubingcoupled to the outer cannula; a flexible torque component including aflexible torque coil or a flexible torque rope, the flexible torquecomponent coupled to the inner cannula and configured to cause the innercannula to at least one of rotate or reciprocate relative to the outercannula to remove the material; and an aspiration channel having anaspiration port configured to engage with a vacuum source, theaspiration channel partially defined by an inner wall of the innercannula and extending from an opening defined in the inner cannula tothe aspiration port.

These and other aspects and implementations are discussed in detailbelow. The foregoing information and the following detailed descriptioninclude illustrative examples of various aspects and implementations,and provide an overview or framework for understanding the nature andcharacter of the claimed aspects and implementations. The drawingsprovide illustration and a further understanding of the various aspectsand implementations, and are incorporated in and constitute a part ofthis specification.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are not intended to be drawn to scale. Likereference numbers and designations in the various drawings indicate likeelements. For purposes of clarity, not every component can be labeled inevery drawing. In the drawings:

FIG. 1A shows a perspective view of an endoscopic tool and a portion ofa drive assembly configured to drive the endoscopic tool according toembodiments of the present disclosure.

FIG. 1B shows a perspective view of the endoscopic tool and the portionof the drive assembly configured to drive the endoscopic tool shown inFIG. 1A according to embodiments of the present disclosure.

FIG. 2 shows a top view of the endoscopic tool and a top exposed view ofthe portion of the drive assembly shown in FIGS. 1A-1B according toembodiments of the present disclosure.

FIG. 3 shows a cross-sectional view of the endoscopic tool and theportion of the drive assembly across the section A-A shown in FIGS.1A-1B according to embodiments of the present disclosure.

FIG. 4 shows an enlarged view of the drive connector of the endoscopeand the portion of the drive assembly shown in FIGS. 1A-1B according toembodiments of the present disclosure.

FIG. 5 shows a perspective view of the endoscopic tool and a portion ofthe drive assembly shown in FIGS. 1A-1B according to embodiments of thepresent disclosure.

FIG. 6 shows a cross-sectional view of the endoscopic tool and theportion of the drive assembly across the section B-B according toembodiments of the present disclosure.

FIG. 7 shows an enlarged cross-sectional view of the rotational couplersection of the endoscopic tool according to embodiments of the presentdisclosure.

FIG. 8A and FIG. 8B show a top view and a cross-sectional view of therotational coupler of the endoscopic tool according to embodiments ofthe present disclosure.

FIG. 9 is a perspective view of a portion of the endoscopic toolinserted for operation within a drive assembly according to embodimentsof the present disclosure.

FIGS. 10-20 illustrate images of an endoscopic pancreatic procedure.

FIG. 21 is a schematic diagram of a torso region of a subject at whichan endoscopic pancreatic procedure can be performed.

FIG. 22 is a flow diagram of a method of performing an endoscopicpancreatic procedure using an endoscopic tool.

FIG. 23 is a schematic diagram of a sheath that couples an endoscopicinstrument with an endoscope.

FIG. 24 is a schematic diagram of a reciprocator for reciprocating aninner cutter of an endoscopic tool.

DETAILED DESCRIPTION A. Endoscopic Instrument Systems and Methods

Technologies provided herein are directed towards an improved flexibleendoscopic instrument that can precisely and efficiently obtain samplesof single and multiple polyps and neoplasms from a patient. Inparticular, the improved endoscopic instrument is capable of debridingsamples from one or more polyps and necrotic material, retrieving thedebrided samples without having to remove the endoscopic instrument fromthe treatment site within the patient's body.

The present disclosure will be more completely understood through thefollowing description, which should be read in conjunction with thedrawings. In this description, like numbers refer to similar elementswithin various embodiments of the present disclosure. Within thisdescription, the claims will be explained with respect to embodiments.The skilled artisan will readily appreciate that the methods, apparatusand systems described herein are merely exemplary and that variationscan be made without departing from the spirit and scope of thedisclosure.

Although the present disclosure is directed towards endoscopicinstruments adapted for use with any type of endoscope, for sake ofconvenience, the teachings of the present disclosure are directedtowards endoscopic instruments used with a lower GI scope, such as acolonoscope. It should, however, be appreciated that the scope of thepresent disclosure is not limited to endoscopic instruments for use withGI scopes, but extends to any type of flexible endoscope, including butnot limited to bronchoscopes, gastroscopes and laryngoscopes, or othermedical devices that may be used to treat patients.

The endoscopic instrument can include a debriding component that maygenerally be configured to debride a polyp. Debriding can, for example,include any action involving detaching the polyp or a portion of thepolyp from a surface of the patient's body. Accordingly, actions,including but not limited to, cutting, snaring, shredding, slicing,shattering, either entirely or partially, are also examples ofdebriding. Accordingly, the debriding component may be a component thatis capable of cutting, snaring, shredding, slicing, shattering, a polypfrom a surface of the patient's body. As such, the debriding componentmay be implemented as a forceps, scissor, knife, snare, shredder, or anyother component that can debride. In some embodiments, the debridingcomponent may be manually actuated such that the debriding component maybe operated through the translation of mechanical forces exerted by anoperator or automatically actuated, using a turbine, electrical motor,or any other force generating component to actuate the debridingcomponent. For instance, the debriding component may be actuatedhydraulically, pneumatically, or electrically. In various embodiments, aseparate conduit passing through the tubing or a channel of theendoscope may be configured to carry an electrical wire to provide powerto the electrically powered actuator, such as an electrical motor.

The debriding component may be manually operated or may utilize anyother means of debriding material such that the debrided material arecapable of being retrieved from the surgical site via the suctionconduit described above. Accordingly, examples of debriding componentsmay include, but are not limited to, snips, blades, saws, or any othersharp tools that may or may not be driven by a turbine assembly. Itshould be appreciated that using a debriding component that is able tocut material into small enough pieces may be desirable such that the cutpieces may be retrieved via the suction conduit without having to removethe endoscopic instrument from the endoscope.

An endoscope may be designed to facilitate debriding one or more polypsand necrotic material and removing the debrided material associated in asingle operation. In various embodiments, the endoscope may include oneor more separate channels for removing debrided material, supplyingirrigation fluid, and supplying and removing at least one of pneumaticor hydraulic fluids. In addition, the endoscope may include a debridingcomponent that may be fixedly or removably coupled to one end of theendoscope. In various embodiments, based on the operation of thedebriding component, a separate debriding component channel may also bedesigned for the debriding component. In addition, the endoscope mayinclude a light and a camera. In one embodiment, the endoscope mayutilize existing channels to supply pneumatic or hydraulic fluids to theactuator of the endoscopic instrument for actuating the debridingcomponent.

In various embodiments, the endoscopic instrument may be configured todetect the presence of certain layers of tissue. This may be useful forphysicians to take extra precautions to prevent bowel perforations whiledebriding polyps. In some embodiments, the endoscopic instrument may beequipped with a sensor that can communicate with a sensor processingcomponent outside the endoscope to determine the type of tissue based onan impedance difference between tissue. The sensor may gathertemperature information as well as density information and providesignals corresponding to such information to the sensor processing unit,which can identify the type of tissue being sensed. In someimplementations, the sensor may be an electrical sensor.

In addition, the endoscopic instrument may be equipped with aninjectable dye component through which a physician may mark a particularregion within the patient's body. In other embodiments, the physicianmay mark a particular region utilizing the debriding component, withoutthe use of an injectable dye.

Although the present disclosure discloses various embodiments of anendoscopic instrument, including but not limited to a tool that may beattached to the tip of the endoscope, and a tool that may be fed throughthe length of the endoscope, the scope of the present disclosure is notintended to be limited to such embodiments or to endoscopic instrumentsin general. Rather, the scope of the present disclosure extends to anydevice that may debride and remove polyps and or necrotic material fromwithin a patient's body using a single tool. As such, the scope of thepresent disclosure extends to improved endoscopes that may be built withsome or all of the components of the endoscopic instruments describedherein. For instance, an improved endoscope with an integrated turbineassembly and configured to be coupled to a debriding component is alsodisclosed herein. Furthermore, the endoscope may also include predefinedconduits that extend through the length of the endoscope such that onlythe suction conduit may be defined by a disposable tubing, while the airentry and exit conduits and the irrigation conduit are permanentlydefined within the improved endoscope. In other embodiments, the suctionconduit is also predefined but made such that the suction conduit may becleaned and purified for use with multiple patients. Similarly, thedebriding component may also be a part of the endoscope, but alsocapable of being cleaned and purified for use with multiple patients.Furthermore, it should be understood by those skilled in the art thatany or all of the components that constitute the endoscopic instrumentmay be built into an existing endoscope or into a newly designedendoscope for use in debriding and removing polyps from within thepatient's body.

In some implementations, an endoscopic instrument insertable within asingle instrument channel of an endoscope can include a power driveninstrument head or cutting assembly that is configured to resectmaterial at a site within a subject. The cutting assembly includes anouter cannula and an inner cannula disposed within the outer cannula.The outer cannula defines an opening through which material to beresected enters the cutting assembly. The endoscopic instrument alsoincludes a flexible outer tubing coupled to the outer cannula andconfigured to cause the outer cannula to rotate relative to the innercannula. The flexible outer tubing can have an outer diameter that issmaller than the instrument channel in which the endoscopic instrumentis insertable. The endoscopic instrument also includes a flexible torquecoil having a portion disposed within the flexible outer tubing. Theflexible torque coil having a distal end coupled to the inner cannula.The flexible torque coil is configured to cause the inner cannula torotate relative to the outer cannula. The endoscopic instrument alsoincludes a proximal connector coupled to a proximal end of the flexibletorque coil and configured to engage with a drive assembly that isconfigured to cause the proximal connector, the flexible torque coil andthe inner cannula to rotate upon actuation. The endoscopic instrumentalso includes an aspiration channel having an aspiration port configuredto engage with a vacuum source. The aspiration channel is partiallydefined by an inner wall of the flexible torque coil and an inner wallof the inner cannula and extends from an opening defined in the innercannula to the aspiration port. The endoscopic instrument also includesan irrigation channel having a first portion defined between an outerwall of the flexible torque coil and an inner wall of the flexible outertubing and configured to carry irrigation fluid to the aspirationchannel.

In some implementations, the proximal connector is hollow and an innerwall of the proximal connector defines a portion of the aspirationchannel. In some implementations, the proximal connector is a rigidcylindrical structure and is configured to be positioned within a drivereceptacle of the drive assembly. The proximal connector can include acoupler configured to engage with the drive assembly and a tensioningspring configured to bias the inner cannula towards a distal end of theouter cannula. In some implementations, the tensioning spring is sizedand biased such that the tensioning spring causes a cutting portion ofthe inner cannula to be positioned adjacent to the opening of the outercannula. In some implementations, the proximal connector is rotationallyand fluidly coupled to the flexible torque coil. In someimplementations, the tensioning spring can be sized and biased such thatthe distal tip of the inner cannula can contact the inner distal wall ofthe outer cannula. This may limit any lateral or undesired movementgenerated due to whip at the distal end of the inner cannula caused bythe rotation of the flexible torque coil.

In some implementations, the endoscopic instrument also includes alavage connector including an irrigation entry port and a tubular membercoupled to the lavage connector and the flexible outer tubing. An innerwall of the tubular member and the outer wall of the flexible torquecoil can define a second portion of the irrigation channel that isfluidly coupled to the first portion of the irrigation channel. In someimplementations, the endoscopic instrument also includes a rotationalcoupler coupling the flexible outer tubing to the tubular member andconfigured to cause the flexible outer tubing to rotate relative to thetubular member and cause the opening defined in the outer cannula torotate relative to the inner cannula. In some implementations, thelavage connector defines an inner bore within which the flexible torquecoil is disposed.

In some implementations, the endoscopic instrument also includes alining within which the flexible torque coil is disposed, the outer wallof the lining configured to define a portion of the irrigation channel.In some implementations, the inner cannula is configured to rotate abouta longitudinal axis of the inner cannula and relative to the outercannula and the aspiration channel is configured to provide a suctionforce at the opening of the inner cannula.

In some implementations, the flexible torque coil includes a pluralityof threads. Each of the plurality of threads can be wound in a directionopposite to a direction in which one or more adjacent threads of theplurality of threads is wound. In some implementations, the flexibletorque coil includes a plurality of layers. Each of the plurality oflayers can be wound in a direction opposite to a direction in which oneor more adjacent layers of the plurality of layers is wound. In someimplementations, each layer can include one or more threads. In someimplementations, the flexible cable can be made of three separatethreads or wires. An inner wire can have a left-hand wound, a middlewire can have a right-hand wound and the outer wire can have a left-handwound. In some implementations, the inner wire can have a right-handwound, a middle wire can have a left-hand wound and the outer wire canhave a right-hand wound. In some implementations, the flexible cable canbe made of two separate threads or wires. In some such implementations,the inner wire can have a left-hand wound and the outer wire can have aright-hand wound. In some other implementations, the inner wire can havea right-hand wound and the outer wire can have a left-hand wound. Insome implementations, the wire rope strands can be twisted in eitherZ-lay or S-lay. Examples of flexible cables include wire ropes andtorque coils manufactured by ASAHI INTECC. In some implementations, theouter diameter of the torque rope or coil is limited by the size of theworking channel of the endoscope with which the endoscopic tool will beused. Other size considerations that need to be taken into accountinclude providing enough space for the aspiration channel, irrigationchannel, amongst others. In some implementations, the outer diameter ofthe torque coil or torque rope can range between 0.1 mm and 4 mm. Insome implementations, the torque coil or rope can have an outer diameterof 0.5 mm to 2.0 mm.

In some implementations, the flexible outer tubing has a length thatexceeds the length of the endoscope in which the endoscopic instrumentis insertable. In some implementations, the flexible outer tubing has alength that is at least 100 times larger than an outer diameter of theflexible outer tubing. In some implementations, the flexible portion isat least 40 times as long as the cutting assembly.

FIGS. 1A-1B show a perspective view of an endoscopic tool 100 and aportion of a drive assembly 150 configured to drive the endoscopic tool.FIG. 1B shows a perspective view of the endoscopic tool and the portionof the drive assembly configured to drive the endoscopic tool shown inFIGS. 1A-1B. Referring now also to FIGS. 2, 3, and 4, FIG. 2 shows a topview of the endoscopic tool 100 and a top exposed view of the portion ofthe drive assembly 150 shown in FIGS. 1A-1B. FIG. 3 shows across-sectional view of the endoscopic tool 100 and the portion of thedrive assembly 150 across the section A-A. FIG. 4 shows an enlarged viewof the drive connector of the endoscope and the portion of the driveassembly 150. FIG. 5 shows a perspective view of the endoscopic tool 100and a portion of the drive assembly shown in FIGS. 1A-1B. FIG. 6 shows across-sectional view of the endoscopic tool and the portion of the driveassembly across the section B-B. FIG. 7 shows an enlargedcross-sectional view of the rotational coupler section of the endoscopictool. FIG. 8A and FIG. 8B show a top view and a cross-sectional view ofthe rotational coupler of the endoscopic tool.

The endoscopic tool 100, as shown in FIGS. 1A-8B, may be configured tobe inserted within an instrument channel of an endoscope. Examples ofthe endoscope can include a gastroscope, such as a colonoscope, alaryngoscope, or any other flexible endoscope. The endoscopic tool caninclude a flexible portion 102 that is shaped, sized and configured tobe inserted within the instrument channel, while a remaining portion ofthe endoscopic tool 100 can be configured to remain outside theinstrument channel of the endoscope. The flexile portion 102 can beshaped and sized to fit within the instrument channel and be configuredto navigate through a tortuous path defined by the instrument channelwhile the endoscope is inserted within the patient. In the case ofcolonoscopes, the endoscope can form a series of bends of over at least60 degrees and in some situations, over 90 degrees.

The endoscopic tool 100 can include a cutting assembly 110 configured toresect material at a site within a subject. In some implementations, thecutting assembly 110 can include an outer cannula and an inner cannuladisposed within the outer cannula. The outer cannula can define anopening 112 through which material to be resected can enter the cuttingassembly 110. In some implementations, the opening 112 is definesthrough a portion of the radial wall of the outer cannula. In someimplementations, the opening may extend around only a portion of theradius of the outer cannula, for example, up to one third of thecircumference of the radial wall. As the aspiration channel 190 extendsbetween the aspiration port 192 and the opening 112, any suction appliedat the aspiration port 192 causes a suction force to be exerted at theopening 112. The suction force causes material to be introduced into theopening of the outer cannula, which can then be cut by the inner cannulaof the cutting assembly.

The inner cannula can include a cutting section that is configured to bepositioned adjacent to the opening 112 such that material to be resectedthat enters the cutting assembly via the opening 112 can be resected bythe cutting section of the inner cannula. The inner cannula may behollow and an inner wall of the inner cannula may define a portion of anaspiration channel that may extend through the length of the endoscopictool. A distal end of the inner cannula can include the cutting sectionwhile a proximal end of the inner cannula can be open such that materialentering the distal end of the inner cannula via the cutting section canpass through the proximal end of the inner cannula. In someimplementations, the distal end of the inner cannula can come intocontact with an inner surface of a distal end of the outer cannula. Insome implementations, this can allow the inner cannula to rotaterelative to the outer cannula along a generally longitudinal axis,providing more stability to the inner cannula while the inner cannula isrotating. In some implementations, the size of the opening can dictatethe size of the materials being cut or resected by the inner cannula. Assuch, the size of the opening may be determined based in part on thesize of the aspiration channel defined by the inner circumference of theflexible torque coil.

The endoscopic instrument 100 can include a flexible torque coil 180that is configured to couple to the proximal end of the inner cannula ata distal end of the flexible torque coil 180. The flexible torque coilcan include a fine coil with multiple threads and multiple layers, whichcan transmit the rotation of one end of the flexible torque coil to anopposite end of the flexible torque coil. Each of the layer of thread ofthe flexible torque coil can be wound in a direction opposite to adirection in which each of the layer of thread adjacent to the layer ofthread is wound. In some implementations, the flexible torque coil caninclude a first layer of thread wound in a clockwise direction, a secondlayer of thread wound in a counter-clockwise direction and a third layerof thread wound in a clockwise direction. In some implementations, thefirst layer of thread is separated from the third layer of thread by thesecond layer of thread. In some implementations, each of the layers ofthread can include one or more threads. In some implementations, thelayers of thread can be made from different materials or have differentcharacteristics, such as thickness, length, among others.

The flexibility of the torque coil 180 allows the coil to maintainperformance even in sections of the torque coil 180 that are bent.Examples of the flexible torque coil 180 include torque coils made byASAHI INTECC USA, INC located in Santa Ana, Calif., USA. In someimplementations, the flexible torque coil 180 can be surrounded by asheath or lining to avoid frictional contact between the outer surfaceof the flexible torque coil 180 and other surfaces. In someimplementations, the flexible torque coil 180 can be coated withPolytetrafluoroethylene (PFTE) to reduce frictional contact between theouter surface of the flexible torque coil 180 and other surfaces. Theflexible torque coil 180 can be sized, shaped or configured to have anouter diameter that is smaller than the diameter of the instrumentchannel of the endoscope in which the endoscopic tool is to be inserted.For example, in some implementations, the outer diameter of the flexibletorque coil can be within the range of 1-4 millimeters. The length ofthe flexible torque coil can be sized to exceed the length of theendoscope. In some implementations, the inner wall of the flexibletorque coil 180 can be configured to define another portion of theaspiration channel that is fluidly coupled to the portion of theaspiration channel defined by the inner wall of the inner cannula of thecutting assembly 110. A proximal end of the flexible torque coil 180 canbe coupled to a proximal connector assembly 170, details of which areprovided below.

The endoscopic instrument 100 can include a flexible outer tubing 186that can be coupled to the proximal end of the outer cannula. In someimplementations, a distal end of the flexible outer tubing 186 can becoupled to the proximal end of the outer cannula using a couplingcomponent. In some implementations, the outer cannula can be configuredto rotate responsive to rotating the flexible outer tubing. In someimplementations, the flexible outer tubing 186 can be a hollow, braidedtubing that has an outer diameter that is smaller than the instrumentchannel of the endoscope in which the endoscopic instrument 100 is to beinserted. In some implementations, the length of the flexible outertubing 186 can be sized to exceed the length of the endoscope. Theflexible outer tubing 186 can define a bore through which a portion ofthe flexible outer tubing 186 extends. The flexible outer tubing 186 caninclude braids, threads, or other features that facilitate the rotationof the flexible outer tubing 186 relative to the flexible torque coil,which is partially disposed within the flexible outer tubing 186.

The endoscopic instrument 100 can include a rotational coupler 130configured to be coupled to a proximal end of the flexible outer tubing186. The rotational coupler 130 may be configured to allow an operatorof the endoscopic tool to rotate the flexible outer tubing 186 via arotational tab 132 coupled to or being an integral part of therotational coupler 130. By rotating the rotational tab 132, the operatorcan rotate the flexible outer tubing and the outer cannula along alongitudinal axis of the endoscope and relative to the endoscope and theinner cannula of the cutting assembly 110. In some implementations, theoperator may want to rotate the outer cannula while the endoscopicinstrument is inserted within the endoscope while the endoscope iswithin the patient. The operator may desire to rotate the outer cannulato position the opening of the outer cannula to a position where theportion of the radial wall of the outer cannula within which the openingis defined may aligned with the camera of the endoscope such that theoperator can view the material entering the endoscopic instrument forresection via the opening. This is possible in part because the openingis defined along a radial wall extending on a side of the outer cannulaas opposed to an opening formed on the axial wall of the outer cannula.

In some implementations, a proximal end 134 of the rotational coupler130 can be coupled to a lavage connector 140. In some implementations,the rotational coupler 130 can be a rotating luer component that allowsa distal end 136 of the rotational coupler 130 rotate relative to theproximal end 134 of the rotational coupler 130. In this way, when theflexible outer tubing 186 is rotated, the component to which theproximal end of the rotational coupler 130 is coupled, is not caused torotate. In some implementations, the proximal end 134 of the rotationalcoupler 130 can be coupled to an outer tubular member 144 configured tocouple the proximal end 134 of the rotational coupler 130 to the lavageconnector 140. The rotational coupler 130 can define a bore along acentral portion of the rotational coupler 130 through which a portion ofthe flexible torque coil 180 extends. In some implementations, therotational coupler 130 can be a male to male rotating luer connector. Insome implementations, the rotational coupler can be configured to handlepressures up to 1200 psi.

The lavage connector 140 can be configured to introduce irrigation fluidinto the endoscopic tool 100. The lavage connector 140 includes a lavageport 142 configured to engage with an irrigation source, such as a watercontainer. In some implementations, the lavage connector 140 can be a Yport used in fluid delivery systems that complies with medical deviceindustry standards and is sized to couple to the flexible outer tubing186 or the outer tubular member 144 that serves to couple a distal end148 of the lavage connector 140 to the proximal end 134 of therotational coupler 130. In some implementations, the lavage connectorcan define a hollow channel between the proximal end 146 and the distalend 148 of the lavage connector 140 that is sized to allow the flexibletorque coil 180 to pass through the hollow channel defined through thelavage connector 140.

As described above, the proximal connector assembly 170 is configured tobe coupled to a proximal end of the flexible torque coil 180. Theproximal connector assembly 170 can be configured to engage with thedrive assembly 150 that is configured to provide torque to the innercannula via the proximal connector assembly 170 and the flexible torquecoil 180. The proximal connector assembly 170 can further define aportion of the aspiration channel and be configured to fluidly couplethe aspiration channel to a vacuum source to facilitate the removal ofmaterial entering the aspiration channel. In some implementations, aproximal end of the proximal connector assembly 170 can include anaspiration port 192 through which the material that enters theendoscopic tool 100 can be withdrawn from the endoscopic tool 100.

In some implementations, the endoscopic tool 100 can be configured to bedriven by the drive assembly 150. The drive assembly 150 is configuredto provide rotational energy from an energy source to the endoscopictool 100. The drive assembly 150 can include a housing 160 that mayhouse a first beveled gear 154 and a second beveled gear 156 that arepositioned such that the rotation of the first beveled gear 154 causes arotation of the second beveled gear 156. The second beveled gear 156 canbe coupled to a drive receptacle that is sized and shaped to receive andengage with the proximal connector assembly 170 of the endoscopic tool100. In some implementations, the first beveled gear 154 can be coupledto a motor (not shown) or other rotational source via a rotational inputshaft 152.

The proximal connector assembly 170 can include a hollow drive shaft172, a coupler 176 through which the hollow drive shaft 172 passes and atensioning spring 174 coupled to the hollow drive shaft 172. A distalend of the drive shaft 172 can be coupled to the proximal end of theflexible torque coil 180. In some implementations, the drive shaft 172and the flexible torque coil 180 can be permanently coupled to oneanother. In some implementations, the drive shaft 172 and flexibletorque coil 180 can be coupled using a coupler, a press fit, a weld,such as a butt weld, or any other attachment means that allows theflexible torque coil 180 to rotate when the drive shaft 172 rotates andto allow material passing through the flexible torque coil 180 to flowthrough the drive shaft 172. A proximal end of the drive shaft 172 candefine the aspiration port 192. In some implementations, the aspirationport 192 can be configured to engage with a vacuum source causingmaterial entering the opening 112 to flow through the aspiration channel190 and out of the endoscopic tool through the aspiration port 192.

A coupler 176, such as a hex-shaped coupler, can be configured to couplewith the hollow drive shaft. In some implementations, the hex-shapedcoupler is a part of the hollow drive shaft. The coupler 176 can includean outer wall that is configured to engage with an inner wall of a drivereceptacle 158. The drive receptacle 158 is coupled to the secondbeveled gear 156 and is configured to rotate when the second beveledgear 156 rotates. In some implementations, the drive receptacle 158 canbe a hollow cylindrical tube. In some implementations, a proximal end159 of the drive receptacle 158 can include an opening defined by aninner wall of the proximal end of the drive receptacle 158 that has adiameter that smaller than the inner diameter of the remaining portionof the drive receptacle 158. In some implementations, the diameter ofthe opening through the proximal end 159 of the drive receptacle 158 canbe large enough to receive the drift shaft 172 but small enough toprevent the tensioning spring 174 coupled to the drive shaft 172 frompassing through the opening. In some implementations, the inner diameterof the remaining portion of the drive receptacle is sized to engage withthe coupler 176.

The tensioning spring 174 can be biased in such a way that, duringoperation of the endoscopic tool 100, the tensioning spring 174 mayprevent the drive shaft 172, the flexible torque coil 180 and the innercannula from sliding towards the proximal end of the endoscopic tool100. In some implementations, without the tensioning spring 174, theinner cannula may slide away from the distal end of the endoscopic tool100. This may be due to a force applied by the material to be resectedat the opening 112. In some implementations, the tensioning spring 174provides a countering force that prevents the inner cannula from slidingaway from the distal end when the inner cannula comes into contact withthe material to be resected at the opening 112. In some implementations,the tensioning spring 174 can be configured to bias the distal end ofthe inner cannula to contact an inner wall of the distal end of theouter cannula. In some implementations, the tensioning spring 174 can besized and biased such that the distal tip of the inner cannula cancontact the inner distal wall of the outer cannula. This may limit anylateral or undesired movement generated due to whip at the distal end ofthe inner cannula caused by the rotation of the flexible torque coil.

The housing 160 can be configured to engage with an aspiration end cap162 and a locking collar 164. In some implementations, the aspirationend cap 162 can be configured to allow a vacuum source to maintain asecure connection with the aspiration port 192 of the drive shaft 172.In some implementations, the aspiration end cap 162 can be configured toallow the drive shaft 172 to rotate while maintaining a secureconnection between the vacuum source and the aspiration port 192 of thedrive shaft 172. In some implementations, the aspiration end cap 162 canbe configured to be secured to a portion of the housing 160 in such away that the aspiration port of the drive shaft 172 is accessible via anopening of the aspiration end cap 162. In some implementations, thevacuum source can be coupled to the end cap 162 such that the vacuumsource does not rotate along with the proximal end of the drive shaft172. In some implementations, one or more bearings or bushings can beused to allow facilitate a fluid connection between the aspiration port192 of the drive shaft 172 and the vacuum source without causing thevacuum source to rotate with the drive shaft 172.

The locking collar 164 can be configured to secure the lavage connector140 to the proximal connector assembly 170. In some implementations, thelocking collar 164 can be configured to secure a proximal end 146 of thelavage connector 140 to the housing 160 of the drive assembly 150. Thelocking collar 164 can further be configured to prevent the proximalconnector assembly 170 from disengaging with the drive receptacle 158and moving towards the distal end of the endoscopic tool 100. In someimplementations, the locking collar 164 can be configured to secure alining 182 within which the flexible torque coil 180 is disposed to theflexible torque coil 180, the drive shaft 172 or the housing 160. Insome implementations, the lining 182 can serve as a heat shrink toreduce the dissipation of heat generated in the flexible torque coil toother components of the endoscopic tool. In some implementations, theouter wall of the lining 182 can define a portion of the irrigationchannel, while the inner wall of the lining 182 can serve to prevent anymaterial passing through the aspiration channel from escaping throughthe walls of the flexible torque coil. In some implementations, thelining 182 can also prevent the irrigation fluid passing through theirrigation channel to flow into the aspiration channel 190 through thewalls of the flexible torque coil 180.

The distal end 148 of the lavage connector 140 can be configured toengage with an inner wall of the outer tubing 144. In someimplementations, the distal end 148 of the lavage connector 140 can bepress fit into a proximal end of the outer tubing 144. In someimplementations, a connector connecting the distal end 148 of the lavageconnector 140 and the outer tubing can be used. The inner wall of theouter tubing 144 and the outer wall of the lining 182 can define aportion of the irrigation channel 196. The outer tubing 144 can extendfrom the distal end 148 of the lavage connector 140 to a proximal end134 of the rotational coupler 130. The distal end of the outer tubing144 can be configured to engage with the proximal end 134 of therotational coupler 130.

In some implementations, the irrigation channel can extend from theirrigation entry port to the opening of the outer cannula. Theirrigation channel can be defined by the inner wall of the outer tubularmember, the rotational coupler, the inner wall of the outer tubing andthe inner wall of outer cannula. In some implementations, the irrigationchannel can also be defined by the outer wall of the inner cannula andthe outer wall of the flexible torque coil 180. In some implementations,the endoscopic instrument 100 can also include the hollow lining 182that is sized to fit around the flexible torque coil 180. In someimplementations, the hollow lining 182 can serve as a barrier betweenthe irrigation channel 196 and the aspiration channel 190. In someimplementations, the hollow lining 182 can prevent air or other fluidsto seep through the threads of the flexible torque coil 180. Inaddition, the hollow lining can allow the aspiration channel to maintaina suction force throughout the length of the aspiration channel bypreventing air to escape or enter through the threads of the flexibletorque coil 180.

As described above, the cutting assembly 110 includes the outer cannula.The braided tubing 186 is coupled to the outer cannula such thatrotating the rotational tab 132 of the rotational coupler 130 results inrotating the outer cannula. The outer cannula includes the opening 112at a distal end of the outer cannula. The opening is defined within aportion of the radial wall of the outer cannula and may only extendaround a portion of the radius of the outer cannula. As the aspirationchannel 190 extends between the aspiration port 192 and the opening 112,any suction applied at the aspiration port 192 causes a suction force tobe exerted at the opening 112. The suction force causes material to beintroduced into the opening of the outer cannula, which can then be cutby the inner cannula of the cutting assembly. In some implementations,the aspirated material can be collected in a collection cartridge. Insome implementations, the collection cartridge can be fluidly coupled tothe proximal end of the aspiration channel.

The inner cannula is disposed within the outer cannula and configured toresect any material that is sucked into or otherwise enters the opening112 due to the suction force in the aspiration channel 190. The innercannula can cut, resect, excise, debride or shave the material at theopening 112 based in part on the interaction between the cutting surfaceand the wall of the outer cannula that defines the opening. In someimplementations, the rotational movement of the cutting surface relativeto the opening 112 can cause the material to be cut, resected, excised,or shaved. The flexible torque coil is coupled to the inner cannula andcauses the inner cannula to rotate along the longitudinal axis of theinner cannula. As the outer cannula is coupled to the outer tubing andis not rotationally coupled to the inner cannula or flexible torquecoil, the inner cannula rotates relative to the outer cannula. A gapbetween an outer wall of the inner cannula and the inner wall of theouter cannula defines a portion of the irrigation channel through whichirrigation fluid can flow from the lavage connector 140 through theirrigation channel portion defined in part by the outer tubing 144, therotational coupler 130, and the flexible outer tubing 186 towards thecutting surface of the inner cannula. The inner cannula may define aportion of the aspiration channel through which excised or resectedmaterial and the irrigation fluid can flow from the cutting surface ofthe inner cannula towards the aspiration port 192.

The length of the cutting assembly 110 may be sized to allow theendoscopic instrument 100 to traverse through the length of theendoscope while the endoscope is inserted inside a patient. In someimplementations, the endoscope may be disposed within the patient andthe endoscope may include bends that exceed 60 degrees. As such, thelength of the cutting assembly 110 may not exceed a few centimeters. Insome implementations, the length of the cutting assembly 110 may be lessthan 1% of the length of the endoscopic tool 100, or the length of theflexible portion of the endoscope within which the endoscopic tool canbe inserted. As described above, tissue sensing capabilities can beimplemented with the cutting assembly serving as a portion of the tissuesensor.

It should be appreciated that one or more seals, bearings, and othercomponents may be used. Seals may be used to maintain pressure, preventfluid leaks, or to securely engage components to one another. In someimplementations, bearings may be used to allow components to rotaterelative to one another without adversely affecting the components orthe performance of the endoscopic tool.

FIG. 6 shows a cross-sectional view of the endoscopic tool and theportion of the drive assembly across the section B-B. As shown in FIG.6, the second beveled gear 156 may be configured to engage with thedrive receptacle 158 of the drive assembly 150. The proximal connector170 of the endoscopic tool 100, which includes the coupler 176 and thedrive shaft 172, can be inserted disposed within the drive receptacle158. The outer wall of the coupler 176 is sized to engage with the innerwall of the drive receptacle 158 such that when the drive receptacle 158rotates, the coupler 176 also rotates. Because the coupler 176 iscoupled to the drive shaft 172, the drive shaft 172 may also rotate whenthe drive receptacle 158 rotates. The inner wall of the drive shaftdefines a portion of the aspiration channel 190.

FIG. 7 shows an enlarged cross-sectional view of the rotational couplersection of the endoscopic tool. FIG. 8A and FIG. 8B show a top view anda cross-sectional view of the rotational coupler of the endoscopic tool.

As shown in FIGS. 7-8B, the outer tubing 144 is configured to engagewith the rotational coupler 130. The outer tubing 144 surrounds thelining 182, which in turn surrounds the flexible torque coil 180. Theinner wall of the flexible torque coil 180 may define a portion of theaspiration channel 190. The space between the inner wall of the outertubing 144 and the outer wall or surface of the lining 182 defines aportion of the irrigation channel. The tab 132 can be configured to berotated by an operator of the endoscopic tool. In some implementations,the operator can rotate the tab 132 while the endoscopic tool isinserted within the instrument channel of the endoscope and cause theouter cannula to rotate relative to the inner cannula and the endoscope.In this way, the operator can position the opening defined through theouter cannula by rotating the outer cannula to a desired position. Insome implementations, by providing a mechanism through which the outercannula can be rotated relative to the endoscope, an operator does nothave to be concerned about the position of the opening when theendoscopic tool is inserted within the instrument channel of theendoscope as the operator may be able to adjust the position of theopening by causing the outer cannula to rotate while the endoscopic toolis inserted within the endoscope.

FIG. 9 is a perspective view of a portion of the endoscopic toolinserted for operation within a drive assembly. The drive assembly 900includes a drive interface 910 configured to receive the proximalconnector 170 of the endoscopic tool 100. The proximal connector 170 canengage with the drive receptacle of the drive interface 910 to translaterotational energy generated by the drive assembly 900 to the cuttingassembly of the endoscopic tool 100. The drive assembly 900 may includea pump 920 or other fluid displacement device to control the flow ofirrigation fluid into the lavage port 142 of the endoscopic tool 100. Insome implementations, the pump 920 can be a peristaltic pump. In someimplementations, the pump can be any positive displacement fluid pump.In some implementations, a valve between the pump 920 and the lavageport 142 can be placed to control an amount of irrigation fluid enteringthe endoscopic tool. In some implementations, the speed at which thepump 920 operates can dictate the rate at which irrigation fluid entersthe endoscopic tool. The drive assembly can also include a pinch valve930. In some implementations, the pinch valve can be configured tocontrol the application of a suction force applied to the aspirationchannel.

In some implementations, an actuator, such as a control switch can beused to actuate the drive assembly 900. In some implementations, theactuator can be a foot pedal, a hand switch, or any other actuationmeans for controlling the drive assembly 900. In some implementations,the actuator can be coupled to the drive means, such as the pump 920such that when the actuator is actuated, the pump 920 begins to rotate,generating torque, which is translated to the proximal connector of theendoscopic tool via the drive interface 910. The torque applied to theproximal connector can be translated via the flexible torque coil to theinner cannula, thereby causing the inner cannula to rotate relative tothe outer cannula. In some implementations, the actuator can be coupledto a pinch valve, such as the pinch valve 930 to control the amount ofsuction applied to the aspiration channel. In some implementations, theactuator can be configured to actuate both the drive means and the pinchvalve simultaneously, such that the inner cannula is rotating whilesuction is applied through the aspiration channel. In someimplementations, the actuator can also be coupled to an irrigationcontrol switch or valve that controls the flow of irrigation fluid intothe endoscopic tool via the irrigation entry port 142. In someimplementations, the actuator can be configured to actuate the drivemeans, the pinch valve for aspiration and the irrigation control switchfor irrigation simultaneously, such that the inner cannula is rotatingwhile suction is applied through the aspiration channel and irrigationfluid is supplied to the endoscopic tool.

In some implementations, a separate irrigation control switch can beconfigured to control the flow of irrigation fluid through theirrigation channel of the endoscopic tool. An operator can control thevolume of irrigation fluid provided to the irrigation channel via theirrigation control switch.

The drive assembly configuration shown in FIGS. 1A-9 is one exampleconfiguration of a drive assembly. It should be appreciated that theendoscopic tool 100 can be configured to be driven by other driveassembly configurations. In some implementations, the proximal connectorportion of the endoscopic tool 100 can be modified to engage with otherdrive assembly configurations. In some implementations, the endoscopictool 400 can be configured to be packaged as one or more differentcomponents that can be assembled prior to inserting the endoscopic toolwithin the instrument channel of the endoscope. In some implementations,the proximal connector of the endoscopic tool 100 can be assembledtogether by an operator of the endoscopic tool after one or morecomponents of the endoscopic tool are caused to engage with componentsof the drive assembly.

It should be appreciated that the outer diameter of the endoscopicinstrument may be sized to be inserted within the instrument channel ofan endoscope while the endoscope is inserted within a patient. Inaddition, the endoscopic instrument may be sized to be large enough thatthe endoscopic tool comes into contact with the inner walls of theinstrument channel at various portions of the instrument channel tomaintain stability of the endoscopic instrument. If the outer diameterof the endoscopic instrument is much smaller than the inner diameter ofthe instrument channel, there may be a large amount of space between theendoscopic instrument and the inner wall of the instrument channel,which may allow the endoscopic instrument to move, vibrate or otherwiseexperience some instability during operation.

B. Systems and Methods for Removing Materials from the Pancreas Using anEndoscopic Surgical Tool

Pancreatic procedures may be performed to address necrotic tissue thatcan result in fluid collections in the pancreas or external to thepancreas, such as due to walled-off pancreatic necrosis. Around twentypercent of subjects with acute pancreatitis develop necrotizingpancreatitis, with about a third of them progressing to infectednecrosis. Infected necrosis may not respond to conservative treatment,such that invasive or interventional treatment may be necessary. Someendoscopic procedures have been used to treat these conditions; however,these procedures may rely on devices designed for other indications,such as lithotripsy baskets, retrieval nets, polypectomy snares, andgrasping forceps, which may be able to grasp and hold material, but lacka sufficient grasp on the necrotic tissue. This can make the procedurescumbersome, time consuming, and limited in effectiveness, oftenrequiring numerous cycles of tissue resection and suction in order tocomplete the treatment (e.g., only small amounts of necrosis beingpulled out per pass).

In accordance with various aspects of the present disclosure, subjectswith infected walled-off pancreatic necrosis can be endoscopicallytreated using an endoscopic tool. Procedures can be performed underconscious or propofol sedation. The endoscopic tool can be coupled withan endoscope, such as to be advanced through an instrument channel oraccessory channel of the endoscope, or coupled to the endoscope by asheath. A cutting assembly of the endoscopic tool can be driven (e.g.,rotated or reciprocated) to remove material such as infected tissue,which can be immediately removed by applying suction to an aspirationchannel of the endoscopic tool. The cutting assembly can be used toremove material associated with fluid collections in the pancreas aswell as external to the pancreas. The endoscopic tool can be guided intothe stomach of the subject (e.g., in conjunction with the endoscope),and introduced to a site from which to remove the material through anopening, such as a cystgastrostomy generated using a stent, in a cavitywall of the stomach. For example, the stent may be used to create afistula through which an interior of the pancreas can be accessed by theendoscopic tool.

In some embodiments of procedures performed in accordance with thepresent disclosure, the average procedure length was 46.5 minutes (range32-80). To achieve complete removal of pancreatic necrosis the mediannumber of required procedures was two per patient (range 1-7). Noprocedure-related adverse events occurred. Endoscopists agree on theease of use and effective removal of necrotic tissue with the ENDOROTOR,rating both 8.3 on a 10-point scale. They are especially satisfied bythe ability to manage the removal of necrotic tissue in a controlled way(8.6 on a 10-point scale).

The endoscopic tool can be used in the gastrointestinal tract for benignneoplastic or pre-malignant tissue removal by interventionalgastroenterologists and GI surgeons. The endoscopic tool can performboth tissue dissection and resection with a single device through anendoscope's instrument biopsy channel. A motorized rotating cutting tooldriven by an electronically controlled console can perform tissueresection. The system can automatically suction and cut between 1000 and1750 times a minute, such that resected tissue can be immediatelyaspirated away from the resection site and collected onto a micronfilter. Tissue collected on the filters can be used for pathologicalexamination using standard methods. FIGS. 10-20 illustrate variousoperations associated with performing endoscopic procedures to addresspancreatic necrosis.

Infected walled of necrosis (WON) is a complication of acutepancreatitis. Direct endoscopic intervention can remove the necrosis andimprove patient recovery. Existing procedures employ the use ofinstruments not designed for the procedure such as endoscopicsnares/jumbo forceps to break up necrosis followed by endoscopicretrieval baskets to remove necrotic debris. The ability of theendoscopic tool to resect tissue may provide faster rates of removal andless endoscopic procedures in this patient population.

Acute pancreatitis can be defined by sudden inflammation of thepancreatic gland, which functions to make insulin and enzymes for thedigestion of food. While the cause of acute pancreatitis can varygreatly among patients, severe cases can lead to development of lifethreatening complications, such as walled-off pancreatic necrosis(WOPN). Pancreatic necrosis can be defined when more than 30% of thegland is affected by necrosis with 20% of patients requiring severeclinical course. Of the 20%, one third (33.3%) of cases may progress toinfected necrosis with patient mortality ranging from 15-30%. Shouldacute necrotic collections continue to progress, results may lead to thedevelopment of WOPN after 4 weeks time.

The endoscopic tool can enable safe and effective removal of pancreaticnecrosis—due to its automated mechanical characteristics, whichincorporate rotational cutting and suction for tissue removal in oneinclusive device. In some embodiments, the endoscopic tool is theENDOROTOR manufactured by Interscope, Inc. of Whitinsville, Mass. Theprocedure can utilize the endoscopic tool in necrosectomy procedures toresect or remove WOPN accessed via trans gastric fistulas created byluminal apposing metal stents (LAMS) and plastic pig tail stents. Whilethe endoscopic tool is used to resect necrotic tissue in the cavityperforation may not present a risk with no interaction with wall ofpancreas and further there was no evidence of bleeding in the series.The endoscopic tool can demonstrate complete removal of pancreaticnecrosis through various anastomosing stents with no incidences ofperforation or bleeding.

During an initial endoscopy, endoscopic ultrasound (EUS) guidedtransgastric drainage can be performed by creating a fistula from thestomach to directly access the adjacent WOPN site for collection.Pigtail plastic stents and a nasocystic flushing catheter, or LuminalApposing Metal Stents (LAMS), can be positioned.

Subjects can be treated approximately twenty-four hours after theinitial drainage procedure; a second endoscopy can be during which thefistula was dilated with a CRETM Balloon Dilator to 18 mm and can befollowed by initial attempts at necrosectomy with conventionalinstruments. Upon execution of necrosectomy with conventionalinstruments, the amount of necrotic tissue that could be removed wasinsufficient and clinical improvement was not observed. Necrosectomyperformed with the endoscopic tool technique can result in completeremoval of all necrotic tissue and in two sessions with no adverseevents; a subject maybe discharged 7 days after admission.

On average, two (2) sessions may be required to remove the pancreaticnecrosis. Reduction of required procedures to achieve favorable removalof necrotic pancreatic tissue can result in patient discharges within afew weeks versus an average of 6.2 sessions and almost twelve (12) weeksusing conventional instrumentation.

Referring now to FIG. 21, a schematic diagram of a torso region 2100 ofa subject is shown according to an embodiment of the present disclosure.The torso region 2100 can include an esophagus 2110, a stomach 2120, apancreas 2130, and a body cavity 2140 defined by space in the torsoregion 2100 between tissues/organs.

The pancreas 2130 may be in a state of pancreatitis, such as a state ofnecrosis (e.g., WOPN). An endoscopic procedure can be performed asdescribed herein to treat the pancreas 2130. For example, an endoscopictool 2180 (e.g., the ENDOROTOR) can be used to resect material from thepancreas 2130, such as inflamed and/or necrotic material (e.g., acutenecrotic collections). The endoscopic tool 2180 can be used to resectmaterial inside or external to the pancreas. The endoscopic tool 2180includes a distal end 2182 that includes an inner cannula and outercannula that can be rotated relative to one another to cut material,along with suction for withdrawing the cut material through theendoscopic tool 2180. Using the automated mechanical characteristics ofthe endoscopic tool, which incorporate rotational cutting and suctionfor tissue removal in one inclusive device, the treatment can beperformed more effectively than existing procedures that rely on snaresor forceps for resect and endoscopic baskets for retrieval. Theendoscopic tool 2180 can have a diameter greater than or equal to 3 mmand less than or equal to 7 mm (e.g., 3.1 mm); for example, as thediameter of the endoscopic tool 2180 increases, suction of material canbe facilitated. The inner cannula can be rotated at a rotation rategreater than or equal to 700 revolutions per minute (RPM) and less thanor equal to 2000 RPM (e.g., at a predetermined rate, such as 1000 RPM or1700 RPM), which can enable the endoscopic tool 2180 to remove materialmore efficiently than in existing procedures, such as by chopping thenecrotic tissue into small pieces. Suction can be applied at a vacuumpressure greater than or equal to 200 mmHg and less than or equal to 750mmHg (e.g., 620 mmHg) to remove the material through the aspirationchannel.

A plurality of cystgastrostomies, such as fistulas 2150, can begenerated to enable access for the endoscopic tool 2180 out of thestomach 2120 and into the pancreas 2130. In some embodiments, aplurality of stents 2152 are used to generate respective fistulas 2150.The stents 2152 can include at least one of luminal apposing metalstents (LAMS), metal stents (e.g., fully covered metal stents), orplastic pig tail stents. As shown in FIG. 21, the stents 2152 are usedto generate respective fistulas 2150 enabling access from the stomach2120 to the pancreas 2130 by generating a channel through an opening ina stomach wall 2122 of the stomach and an opening in a pancreas wall2132 of the pancreas 2130. One or more fistulas 2154 may also begenerated remote from the stomach wall 2122, to enable access into thepancreas 2130 via the body cavity 2140. One or more fistulas 2154 mayalso be generated on the stomach wall 2122 to enable access to infectedtissue outside of the pancreas 2130.

The endoscopic tool 2180 can be introduced into the pancreas 2130 viaone or more of the fistulas 2152, 2154. For example, the endoscopic tool2180 can be introduced through the esophagus 2110, into the stomach2120, and then through one or more fistulas 2152 into the pancreas 2130.The endoscopic tool 2180 can also be introduced into the body cavity2140 separately from the esophagus 2110 or other gastrointestinalpathways, and then through one or more fistulas 2154 into the pancreas2130. The endoscopic tool 2180 can be introduced through an instrumentchannel or accessory channel of an endoscope (which may be external tothe endoscope), or can be introduced externally to the endoscope, suchas by using a sheath that couples the endoscopic tool 2180 and theendoscope (e.g., sheath 2310 described with reference to FIG. 23).

When positioned adjacent to a site in the subject from which to removematerial, such as a site in the pancreas 2130, the endoscopic tool 2180can be actuated to cut and remove material from the pancreas 2130,including inflamed or necrotic material (see FIGS. 10-20). For example,an image capture device of the endoscopic tool 2180 can be used to guidethe endoscopic tool 2180 towards a material, the distal end 2185 can bepositioned adjacent to the material, and the endoscopic tool 2180 can beactuated to cut the material (e.g., by rotating the inner cannularelative to the outer cannula). Suction can be applied via the distalend 2185 to remove the cut material.

In some embodiments, the distal end 2185 is positioned to be tangent orsubstantially tangent to a tissue plane of the material to be removed.For example, the distal end 2185 can be positioned such that the cuttingwindow of the cutting assembly is rotated to be facing the material withnear or direct contact of the inner cannula (e.g., the distal end 2185is within a threshold distance of the tissue plane less than or equal toten millimeters), which has been found to improve the ability of theendoscopic tool 2180 to break up the material for suction through theaspiration channel (e.g., vacuum alone may not be sufficient to removethe material). In some embodiments, the cutting window is adjusted to bewithin a threshold angle of tangent to the tissue plane. The thresholdangle can be fifteen degrees. The threshold angle can be ten degrees.The threshold angle can be five degrees. The cutting window can beadjusted so that a rotation or reciprocation axis of the inner cannulais parallel to the tissue plane where the inner cannula contacts thetissue plane within the threshold angle. In some embodiments, thecutting window is positioned so that the tissue plane is between thecavity wall and the cutting window (e.g., to trap the necrotic tissuebetween the cavity wall and the cutter opening), which can facilitatetissue removal and subsequent suction.

Referring now to FIG. 22, a method 2200 of performing an endoscopicpancreatic procedure is shown. The method 2200 can be performed usingvarious embodiments of endoscopic tools described herein, such as theENDOROTOR. The method 2200 or steps thereof can be repeated, such as toaddress multiple sites having multiple materials of necrotic tissue tobe removed, both inside and outside the pancreas.

At 2210, at least one cystgastrostomy is generated. The cystgastrostomycan be an opening generated on a cavity wall of a stomach of thesubject. The cystgastrostomy can be used to provide access from thestomach into a pancreas of the subject or a body cavity proximate to thepancreas in which necrotic tissue or fluid collections from the pancreasare located. For example, the cystgastrostomy can be generated throughthe cavity wall of the stomach and a pancreas wall of a pancreas of asubject.

The at least one cystgastrostomy can be generated as a fistula, in someembodiments. The at least one fistula can be generated using arespective stent. The stent can include at least one of a luminalapposing metal stent (LAMS), a hot axios stent, or a plastic pig tailstent. In some embodiments, generating the fistula includes generatingan opening through a stomach wall of the stomach and the pancreas wall.In some embodiments, generating the fistula includes generating anopening on the pancreas wall remote from the stomach wall, to enableaccess into the pancreas via a body cavity of the subject (rather thanvia a gastrointestinal pathway, such as via an esophagus).

At 2220, a site having material to be removed from the subject isaccessed by introducing an endoscopic tool through the at least onecystgastrostomy. For example, the endoscopic tool can be introduced intothe pancreas via the at least one cystgastrostomy. In some embodiments,the endoscopic tool is introduced into the pancreas via the esophagus,the stomach, and at least one cystgastrostomy providing a channel fromthe stomach into the pancreas. In some embodiments, the endoscopic toolis introduced into the pancreas via the body cavity and acystgastrostomy on the pancreas wall remote from the stomach wall. Insome embodiments, the site is external to the pancreas (e.g., associatedwith a fluid collection that has left the pancreas), and can be accessedthrough a cystgastrostomy generated on the stomach wall.

At 2230, the endoscopic tool is guided to the material. The material canbe inflamed or necrotic material. Guiding the endoscopic tool caninclude using an image capture device of the endoscopic tool to identifythe material, and moving a distal end of the endoscopic tool towards thematerial, such as to position the distal end adjacent to the material.The endoscopic tool can be guided to a plurality of locations ofmaterials. The structure of the endoscopic tool can enable theendoscopic tool to follow a tortuous pathway to the material withreduced likelihood of the endoscopic tool (or endoscopic) breaking.

In some embodiments, a tissue plane corresponding to the material isidentified. The tissue plane can include a portion of or extend from acavity wall on which the necrotic tissue to be removed is located. Theendoscopic tool (e.g., a distal end thereof) can be guided to be tangentor substantially tangent to a tissue plane of the material to beremoved. For example, the distal end can be positioned such that acutting window of a cutting assembly of the endoscopic tool at thedistal end can be rotated to be facing the material with near or directcontact of the inner cannula (e.g., the distal end is within a thresholddistance of the tissue plane less than or equal to ten millimeters). Insome embodiments, the cutting window is adjusted to be within athreshold angle of tangent to the tissue plane. The threshold angle canbe fifteen degrees. The threshold angle can be ten degrees. Thethreshold angle can be five degrees. The cutting window can be adjustedso that a rotation or reciprocation axis of the inner cannula isparallel to the tissue plane where the inner cannula contacts the tissueplane within the threshold angle. In some embodiments, the cuttingwindow is positioned so that the tissue plane is between the cavity walland the cutting window (e.g., to trap the necrotic tissue between thecavity wall and the cutter opening).

At 2240, the cutting assembly is actuated to cut the material. Forexample, the inner cannula can be rotated or reciprocated relative tothe outer cannula while in contact with the material to cut thematerial. In some embodiments, a flexible torque component of theendoscopic tool that includes at least one of a flexible torque coil ora flexible torque rope is rotated by a drive assembly to rotate theinner cannula or a reciprocator coupled with the inner cannula thatcauses the inner cannula to reciprocate. The outer cannula can berotated to adjust the cutting window. In some embodiments, the innercannula is rotated at a rotation rate greater than or equal to 700revolutions per minute and less than or equal to 2000 revolutions perminute, such as 1000 revolutions per minute.

At 2250, the endoscopic tool removes the material. The endoscopic toolcan include an aspiration channel that applies vacuum through theendoscopic tool to the distal end (e.g., an opening at the distal endadjacent to the inner cannula) to remove the material through theaspiration channel. For example, a vacuum source can be applied to afirst end of the aspiration channel (e.g., a first end located outsideof the subject) to draw the material from an opening of the innercannula at a second end of the aspiration channel through the aspirationchannel and out of the first opening. The material can be cut andremoved from a plurality of locations of the pancreas or external to thepancreas. The suction can be applied to the aspiration channel at avacuum pressure greater than or equal to 200 mmHg and less than or equalto 750 mmHg. In some embodiments, the suction is applied while thecutting assembly is actuated and in contact with the material, which canallow for more rapid and efficient removal and suction of material ascompared to separate removal and suction actions.

Referring now to FIG. 23, a sheath 2310 that can be used to couple theendoscopic tool 2180 to an endoscope 2320 is shown according to anembodiment of the present disclosure. The sheath 2310 can be used toenable the endoscopic tool 2380 to be outside of the endoscope 2320,such as to increase a range of movement of the endoscopic tool 2380relative to the endoscope 2320. The sheath 2310 can include a workingchannel 2312 through which the endoscopic tool 2180 can be received andadvanced. The sheath 2310 and working channel 2312 can be made from aflexible material, such as a plastic material. The working channel 2312can have a relatively large diameter, such as a diameter of 3.8 mm orgreater.

Referring now to FIG. 24, a reciprocator 2400 for causing reciprocatingmovement of an inner cannula 2404 of an endoscopic tool (e.g.,endoscopic tool 2180) is shown. The reciprocator 2400 can include abushing 2408 coupled with a flexible torque component 2412 (e.g.,flexible torque coil, flexible torque rope) of the endoscopicinstrument, and at least one gear 2416 coupled with the inner cannula2404 and the flexible torque component 2412 via the bushing 2408. The atleast one gear 2416 can convert rotational movement of the flexibletorque component 2412 about a rotational axis 2420 into linear motion ofthe inner cannula 2404. The linear motion may be along the rotationalaxis 2420 or offset from the rotational axis 2420.

Having now described some illustrative implementations, it is apparentthat the foregoing is illustrative and not limiting, having beenpresented by way of example. In particular, although many of theexamples presented herein involve specific combinations of method actsor system elements, those acts and those elements can be combined inother ways to accomplish the same objectives. Acts, elements andfeatures discussed in connection with one implementation are notintended to be excluded from a similar role in other implementations orimplementations.

The phraseology and terminology used herein is for the purpose ofdescription and should not be regarded as limiting. The use of“including” “comprising” “having” “containing” “involving”“characterized by” “characterized in that” and variations thereofherein, is meant to encompass the items listed thereafter, equivalentsthereof, and additional items, as well as alternate implementationsconsisting of the items listed thereafter exclusively. In oneimplementation, the systems and methods described herein consist of one,each combination of more than one, or all of the described elements,acts, or components.

Any references to implementations or elements or acts of the systems andmethods herein referred to in the singular can also embraceimplementations including a plurality of these elements, and anyreferences in plural to any implementation or element or act herein canalso embrace implementations including only a single element. Referencesin the singular or plural form are not intended to limit the presentlydisclosed systems or methods, their components, acts, or elements tosingle or plural configurations. References to any act or element beingbased on any information, act or element can include implementationswhere the act or element is based at least in part on any information,act, or element.

Any implementation disclosed herein can be combined with any otherimplementation or embodiment, and references to “an implementation,”“some implementations,” “one implementation” or the like are notnecessarily mutually exclusive and are intended to indicate that aparticular feature, structure, or characteristic described in connectionwith the implementation can be included in at least one implementationor embodiment. Such terms as used herein are not necessarily allreferring to the same implementation. Any implementation can be combinedwith any other implementation, inclusively or exclusively, in any mannerconsistent with the aspects and implementations disclosed herein.

Where technical features in the drawings, detailed description or anyclaim are followed by reference signs, the reference signs have beenincluded to increase the intelligibility of the drawings, detaileddescription, and claims. Accordingly, neither the reference signs northeir absence have any limiting effect on the scope of any claimelements.

Systems and methods described herein may be embodied in other specificforms without departing from the characteristics thereof. Furtherrelative parallel, perpendicular, vertical or other positioning ororientation descriptions include variations within +/−10% or +/−10degrees of pure vertical, parallel or perpendicular positioning.References to “approximately,” “about” “substantially” or other terms ofdegree include variations of +/−10% from the given measurement, unit, orrange unless explicitly indicated otherwise. Coupled elements can beelectrically, mechanically, or physically coupled with one anotherdirectly or with intervening elements. Scope of the systems and methodsdescribed herein is thus indicated by the appended claims, rather thanthe foregoing description, and changes that come within the meaning andrange of equivalency of the claims are embraced therein.

The term “coupled” and variations thereof includes the joining of twomembers directly or indirectly to one another. Such joining may bestationary (e.g., permanent or fixed) or moveable (e.g., removable orreleasable). Such joining may be achieved with the two members coupleddirectly with or to each other, with the two members coupled with eachother using a separate intervening member and any additionalintermediate members coupled with one another, or with the two memberscoupled with each other using an intervening member that is integrallyformed as a single unitary body with one of the two members. If“coupled” or variations thereof are modified by an additional term(e.g., directly coupled), the generic definition of “coupled” providedabove is modified by the plain language meaning of the additional term(e.g., “directly coupled” means the joining of two members without anyseparate intervening member), resulting in a narrower definition thanthe generic definition of “coupled” provided above. Such coupling may bemechanical, electrical, or fluidic.

References to “or” can be construed as inclusive so that any termsdescribed using “or” can indicate any of a single, more than one, andall of the described terms. A reference to “at least one of ‘A’ and ‘B’”can include only ‘A’, only ‘B’, as well as both ‘A’ and ‘B’. Suchreferences used in conjunction with “comprising” or other openterminology can include additional items.

Modifications of described elements and acts such as variations insizes, dimensions, structures, shapes and proportions of the variouselements, values of parameters, mounting arrangements, use of materials,colors, orientations can occur without materially departing from theteachings and advantages of the subject matter disclosed herein. Forexample, elements shown as integrally formed can be constructed ofmultiple parts or elements, the position of elements can be reversed orotherwise varied, and the nature or number of discrete elements orpositions can be altered or varied. Other substitutions, modifications,changes and omissions can also be made in the design, operatingconditions and arrangement of the disclosed elements and operationswithout departing from the scope of the present disclosure.

References herein to the positions of elements (e.g., “top,” “bottom,”“above,” “below”) are merely used to describe the orientation of variouselements in the FIGURES. It should be noted that the orientation ofvarious elements may differ according to other exemplary embodiments,and that such variations are intended to be encompassed by the presentdisclosure.

What is claimed is:
 1. A method comprising: introducing, via an opening,an endoscopic tool coupled with an endoscope to access a site in atleast one of a peri pancreatic and pancreatic space; actuating a torquecomponent of the endoscopic tool to actuate a cutting assembly of theendoscopic tool to cut material at the site, the material associatedwith at least one of a pancreatic fluid collection in a pancreas of asubject or an extra-pancreatic fluid collection external to thepancreas; and applying suction to a first end of an aspiration channelof the endoscopic tool to remove the material through the aspirationchannel, the aspiration channel defined by the torque component andextending from the first end to a second end at an opening of thecutting assembly.
 2. The method of claim 1, wherein introducing theendoscopic tool comprises: identifying a tissue plane corresponding tothe material; and maneuvering the cutting assembly to the tissue plane.3. The method of claim 2, further comprising positioning the cuttingwindow so that the tissue plane is between a tissue wall from which thetissue plane extends and the cutting window.
 4. The method of claim 2,wherein maneuvering the cutting assembly comprising positioning thecutting assembly within a threshold distance of the tissue plane, thethreshold distance less than or equal to ten millimeters.
 5. The methodof claim 2, further comprising adjusting the cutting window of thecutting assembly to be within a threshold angle of tangent to the tissueplane, the threshold angle less than or equal to fifteen degrees.
 6. Themethod of claim 1, further comprising generating the opening to enableaccess to the site by using at least one of a luminal apposing metalstent (LAMS), a fully covered metal stent, or at least one plastic pigtail stent.
 7. The method of claim 1, further comprising providing theendoscopic tool through at least one of a working channel or anaccessory channel of the endoscope.
 8. The method of claim 1, furthercomprising coupling the endoscopic tool to the endoscope using a sheathexternal to the endoscope.
 9. The method of claim 1, further comprisingproviding the endoscopic tool through a working channel of a sheathexternal to the endoscope.
 10. The method of claim 1, wherein actuatingthe cutting assembly comprises at least one of rotating or reciprocatingan inner cannula of the endoscopic tool, the inner cannula defining theopening through which the material is removed.
 11. The method of claim10, wherein the inner cannula is disposed within an outer cannula. 12.The method of claim 10, wherein rotating the inner cannula comprisesrotating the inner cannula at a rotation rate greater than or equal to700 revolutions per minute and less than or equal to 5000 revolutionsper minute.
 13. The method of claim 1, wherein a diameter of theendoscopic instrument is greater than 3 mm and less than 7 mm.
 14. Themethod of claim 1, further comprising using an image capture device ofthe endoscope to detect one or more images of the material.
 15. Themethod of claim 1, further comprising applying the suction to theaspiration channel at a vacuum pressure greater than or equal to 200mmHg and less than or equal to 750 mmHg.
 16. The method of claim 1,further comprising applying the suction while actuating the cuttingassembly when the cutting assembly is adjacent to the site.
 17. Themethod of claim 1, further comprising introducing the endoscope into astomach of the subject from the esophagus and introducing the endoscopictool from the stomach through the cavity wall.
 18. The method of claim1, further comprising generating the opening by generating one or morefistulas through a stomach opening in a stomach wall and a pancreaticopening in a pancreas wall of the pancreas to access the site in atleast one of the peri pancreatic and pancreatic space.
 19. The method ofclaim 1, further comprising generating the opening by generating one ormore fistulas via a body cavity to enable access to the site in at leastone of the peri pancreatic and pancreatic space.
 20. The method of claim1, further comprising generating the opening by generating one or morefistulas on a stomach wall to enable access to the site in at least oneof the peri pancreatic and pancreatic space outside of the pancreas.